Focused ultrasound is cleared to treat liver tumors in the United States.
The US Food and Drug Administration (FDA) has cleared HistoSonics’ novel therapy platform – called EdisonTM – to treat liver tumors. EdisonTM uses histotripsy to noninvasively destroy tissue in the liver and is the first and only such platform available in the US. This is also the first time the use of histotripsy has earned regulatory approval worldwide. Read More
Focused Ultrasound Therapy
Focused ultrasound is a rapidly evolving, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with liver tumors. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.
How it Works
Where the beams converge, focused ultrasound produces several therapeutic effects that are being evaluated.
One mechanism is the production of precise ablation (thermal destruction of tissue). This destruction can be done to completely destroy the target or to partially treat it, and partial treatment is believed to stimulate the patient’s immune response, which may have a broader impact.
Another mechanism is the use of mechanical (non-thermal) histotripsy to destroy the tumor.
A third mechanism is to use focused ultrasound to cause hyperthermia which enables the local release and absorption of a therapeutic that is contained in the blood stream.
The primary options for treatment of liver tumors include surgery, chemotherapy, radiotherapy, localized destruction of the tumor tissue (via radiofrequency ablation, alcohol injection, cryosurgery, or laser photocoagulation), or combination of two or more of these options. The long-term solution for primary liver cancer is often liver transplantation.
For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary. Focused ultrasound can also enhance the chemotherapy dose for the target, with less impact to the rest of the patient.
A clinical trial in the UK is recruiting patients with colorectal cancer and metastasis to the liver. It uses focused ultrasound to activate a microbubble preparation designed to improve the penetration of chemotherapy to the liver.
A clinical study involves enhancing drug delivery due to heating the thermosensitive lysosome containing chemotherapy with focused ultrasound in pediatric patients and young adults.
For a full list of clinical trials, please click here.
Regulatory Approval and Reimbursement
In October 2023, the US Food and Drug Administration cleared HistoSonics’ Edison device to noninvasively treat liver tumors using histotripsy.
A focused ultrasound system has been approved in China, Russia, Europe, and Korea for treatment of liver cancer.
To the best of our knowledge, the use of focused ultrasound to treat liver cancer is not yet widely reimbursed by medical insurance.
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Click here for additional references from PubMed.
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